Ridgefield, Conn., October 15, 2021
Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab).
The FDA originally approved Cyltezo® in 2017 for the treatment of multiple chronic inflammatory diseases and this latest approval designates it as Interchangeable across all of these indications.
The approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s Phase III randomized VOLTAIRE-X clinical trial and marks the first FDA approval for such a study. The VOLTAIRE-X trial studied the effects of multiple switches between Humira® and Cyltezo®. This additional study demonstrated that Cyltezo® is equivalent to Humira® with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups. The results were presented at the American Academy of Dermatology 2021 conference.
Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn’s disease.
A biosimilar is a biological medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity. An Interchangeable biosimilar must first meet the high FDA standards of a biosimilar. Then, in order to achieve the interchangeable designation, the FDA requires an additional clinical study of multiple substitutions in patients, known as an Interchangeability study. This type of study shows how patients do when they are switched back and forth multiple times from a reference product to the Interchangeable biosimilar candidate. A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the reference product, with individual state laws controlling how and whether physicians will be notified.